FDA EIR - Integrated Medical Systems International Inc. - February 25, 2016

An FDA 'For Cause' inspection of Integrated Medical Systems International Inc.'s Hillsborough, NJ facility occurred from February 17-25, 2016. The inspection focused on the company's repair and refurbishment activities for non-sterile, non-implantable Class I medical devices, specifically surgical endoscopic instruments. Key areas reviewed included incoming device acceptance, repair standards, release processes, customer complaint handling, record-keeping, technician training, facility maintenance, and equipment calibration. The inspection was conducted under the regulatory framework of CP 7382.845, 'Inspection of Medical Device Manufacturers,' and the FDA 'Guide to Inspection of Quality Systems, August 1999.' Crucially, no deficiencies were identified during the inspection, and no Form FDA-483 (Inspectional Observations) was issued to the firm. Consequently, no specific regulatory violations were found, and no immediate corrective or required actions were mandated as a direct result of this inspection. The report noted that the firm had not been involved in any field corrections or removals, nor initiated or responded to any adverse event reports in the preceding 24 months, with one exception for an MDR submitted by headquarters related to a non-repair-caused instrument failure.